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Methotrexate

Ebetrexat, Methofill, Methotrexat Accord, Methotrexat Ebewe · ATC code L04AX03

Also known as: Methotrexat, Metotreksat · Brand names: Ebetrexat, Methofill, Methotrexat Accord, Methotrexat Ebewe, Methotrexat Lederle, Metoject, Metotab, Mtx Ratiopharm, Lantarel, Metex, Methotrexate Gry, Mtx, Artjet, Artroject, Emthexate …

Key facts
Active substance
Methotrexate
Drug class
Immunosuppressive drug
ATC code
L04AX03
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, SEVERE ADVERSE REACTIONS, AND RISK OF MEDICATION ERRORS
• Methotrexate tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, methotrexate tablets are contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].
• Methotrexate tablets are contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [Contraindications (4), Warnings and Precautions (5.2)].
• Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue methotrexate tablets as appropriate [Warnings and Precautions (5.3, 5.4, 5.5, 5.6, 5.7, 5.8)].
• Methotrexate tablets when inadvertently administered once daily have resulted in death [Warnings and Precautions (5.9)].

Key facts

Methotrexate is a folate antagonist (cytotoxic and immunosuppressant). Per the US label (tablets) it is used in certain cancers, rheumatoid arthritis, polyarticular JIA and severe psoriasis.

What it is used for

  • Acute lymphoblastic leukaemia (maintenance, adults and children)
  • Mycosis fungoides; relapsed or refractory non-Hodgkin lymphomas (metronomic regimen)
  • Rheumatoid arthritis in adults
  • Polyarticular juvenile idiopathic arthritis
  • Severe psoriasis in adults

Dosing

  • Rheumatoid arthritis: start 7.5 mg once weekly, escalate to response; more than 20 mg weekly increases the risk of serious adverse reactions
  • pJIA: start 10 mg/m2 once weekly
  • Psoriasis: 10 to 25 mg once weekly; do not exceed 30 mg per week
  • ALL: start 20 mg/m2 once weekly; other oncology regimens in the full text
  • Give folic or folinic acid in non-neoplastic indications
  • Inadvertent once-daily instead of weekly dosing has caused deaths

Contraindications

  • Pregnancy in women treated for non-neoplastic diseases
  • History of severe hypersensitivity reactions, including anaphylaxis, to methotrexate

Important warnings

  • Boxed warning: embryo-fetal toxicity, including fetal death
  • Boxed warning: serious adverse reactions including death – monitor bone marrow, GI tract, liver, lungs, skin and kidneys
  • Boxed warning: medication errors – once-daily dosing in error has been fatal
  • Serious infections, neurotoxicity, secondary malignancies, tumour lysis syndrome

Side effects

  • Common: ulcerative stomatitis, leukopenia, nausea, abdominal distress
  • Infection, malaise, fatigue, chills, fever, dizziness
  • Serious: myelosuppression, hepatotoxicity, pulmonary toxicity, dermatologic reactions, renal toxicity

Interactions

  • Increased methotrexate levels with oral antibiotics, penicillins, sulfonamides, probenecid and highly protein-bound drugs (e.g. oral anticoagulants, phenytoin, salicylates)
  • Hepatotoxic or nephrotoxic products increase organ-specific adverse reactions

Pregnancy and breastfeeding

  • Contraindicated in pregnancy for non-neoplastic diseases; verify pregnancy status before starting
  • For neoplastic diseases, effective contraception for females and males of reproductive potential

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • EbetrexatEbewe Pharma · 5 register entries
  • MethofillAccord Healthcare B.V. · 2 register entries
  • Methotrexat AccordAccord Healthcare B.V. · 2 register entries
  • Methotrexat EbeweEbewe Pharma · 1 register entry
  • Methotrexat LederlePfizer Corporation Austria Ges.M.B.H. · 1 register entry
  • MetojectMedac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel) · 2 register entries
  • MetotabMedac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel) · 2 register entries
  • Mtx RatiopharmTeva B.V · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • LantarelPfizer Pharma Gmbh · 2 register entries
  • MetexMedac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel) · 3 register entries
  • MethofillAccord Healthcare B.V. · 3 register entries
  • MethotrexatMedac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel), Kelix Bio (Malta) Limited, Pfizer Pharma Gmbh, Accord Healthcare B.V., Pharma Resources Gmbh, Stadapharm Gmbh, Teva Gmbh, Aliud Pharma Gmbh · 16 register entries
  • Methotrexate GryTeva Gmbh · 1 register entry
  • MtxHexal Ag, Ratiopharm Gmbh · 4 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • ArtjetFARMAKO ECZACILIK A.Ş. · 8 register entries
  • ArtrojectDEVA HOLDİNG A.Ş. · 5 register entries
  • EmthexateTEVA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • MeksratuKOÇSEL İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
  • Methotrexat 'ebewe' PfsSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • Methotrexat EbeweSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • Methotrexate EbeweSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • MetoartKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 14 register entries
  • RheumetexVEM İLAÇ SAN. VE TİC. A.Ş. · 10 register entries
  • SubmexONKO İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • TrexanATAFARM İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • JylamvoSHORLA ONCOLOGY INC. · 1 register entry
  • OtrexupAntares Pharma, Inc. · 1 register entry
  • RasuvoMedexus Pharma Inc. · 1 register entry
  • TrexallTeva Women's Health LLC · 1 register entry
  • XatmepAzurity Pharmaceuticals, Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 28 more European countries
Belgium
Basitrin, Emthexate, Ledertrexate, Methofill, Methotrexate Accord Healthcare, Metoject
Bulgaria
Ebetrexat, Инжексат, Метотрексат Акорд, Метотрексат Ебеве, Намаксир
Croatia
Ebetrexat, Methofill, Metotreksat Cipla, Metotreksat Sandoz, Namaxir
Cyprus
Injexate, Methotrexate Accord, Methotrexate Pfizer, Methotrexate Remedica
Czechia
Foxiemo, Injexate, Methotrexat Accord, Methotrexat Ebewe, Methotrexát Denk, Metoject, Trexan Neo
Denmark
Ebetrex, Emthexate, Injexate, Metex, Methofill, Methotrexat Accord, Methotrexat Ebewe, Methotrexat Sandoz, Methotrexate Accord, Methotrexate Afortas, Methotrexate Pfizer, Trexan
Estonia
Ebetrex, Metex, Methotrexate Accord, Methotrexate Ebewe, Trexan
Finland
Ebetrex, Injexate, Methotrexat Accord, Methotrexat Ebewe, Methotrexate Ebewe, Methotrexate Stada, Metoject, Trexan
France
Imenor, Imeth, Izixate, Methotrexate Accord, Methotrexate Arrow, Methotrexate Biodim, Methotrexate Teva, Methotrexate Viatris, Metoject, Metotab, Novatrex
Greece
Methobion, Methotrexate Pfizer, Methox-F, Metoject, Μεθοτρεξάτη Accord
Hungary
Ebetrexat, Methofill, Methotrexat Sandoz, Methotrexate Orion, Metoject
Iceland
Jylamvo, Methotrexat Ebewe, Methotrexate Orion Pharma, Methotrexate Pfizer, Metoject, Metojectpen, Nordimet
Ireland
Methofill, Methotrexate Abcur Ab, Methotrexate Accord Healthcare, Methotrexate Aspire Pharma (Malta), Methotrexate Orion, Methotrexate Pfizer, Metoject
Italy
Afslamet, Immutrex, Methotrexate Pfizer Italia, Metother, Metotressato Teva, Metotrexato Aurobindo, Metotrexato Doc Generici, Metotrexato Mylan, Reumaflex, Trexother, Velos
Latvia
Ebetrex, Metex, Methotrexate Accord, Methotrexate Ebewe
Liechtenstein
Jylamvo, Nordimet
Lithuania
Ebetrexat, Metex, Methotrexat Ebewe, Methotrexate Accord, Metother, Trexan
Luxembourg
Emthexate, Ledertrexate
Malta
Methotrexate Aspire Pharma (Malta)
Netherlands
Basitrin, Ebetrex, Emthexate Pf, Injexate, Methotrexaat Accord, Methotrexaat Basic Pharma, Methotrexaat Eugia, Methotrexaat Focus, Methotrexaat Nordic, Methotrexaat Sandoz, Methotrexaat Teva, Metoject
Norway
Ebetrex, Jylamvo, Metex, Methofill, Methotrexat Accord, Methotrexate Afortas, Methotrexate Cipla, Methotrexate Orion, Methotrexate Pfizer, Nordimet
Poland
Ebetrexat, Metex, Methofill, Methotrexat Ebewe, Metotreksat Accord, Namaxir, Trexan Neo, Tullex
Portugal
Fauldexato, Ledertrexato, Metex, Methofill, Methotrexato Teva, Metotrexato A.Forall, Metotrexato Accord, Metotrexato Generis, Metotrexato Teva
Romania
Methotrexat Ebewe, Metorthrit, Metotrexat Sandoz, Metotrexat Vitema, Metotrexate Ebewe, Namaxir
Slovakia
Foxiemo, Injexate, Methotrexat Accord, Methotrexat Sandoz, Metoject, Trexan Neo
Slovenia
Methofill, Metoject, Metotreksat Ebewe
Spain
Bertanel, Imeth, Jiax Semanal, Methofill, Metoject, Metotrexato Accord, Metotrexato Pfizer, Metotrexato Semanal Cipla, Metotrexato Semanal Orion Pharma, Metotrexato Semanal Wyeth, Metotrexato Wyeth, Quinux
Sweden
Ebetrex, Injexate, Methotrexate Accord, Methotrexate Afortas, Methotrexate Ebewe, Methotrexate Orion Pharma, Methotrexate Teva, Metoject, Metojectpen, Metopen, Metotab, Metotrexat Accord, Namaxir

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Methotrexate (AvKARE) – Prescribing Information, 2026-07-23. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=757d6cef-6696-7a1c-8074-01258aaa8bdd
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC L04AX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.